Febutastine 40 mg (Febuxostat)

Adult dosage

1. Adults Administer this medicine 40mg or 80mg once daily, regardless of meals. Because this medicine acts very rapidly, recheck the serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain the serum uric acid concentration below 6 mg/dL(357 μmol/L). 2. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. The safety and efficacy of this medicine have not been adequately evaluated in patients with severe renal impairment (creatinine clearance less than 30mL/min). 3. Patients with hepatic impairment No special dose adjustment is necessary in patients with mild or moderate hepatic impairment. Only limited information is available for patients with moderate hepatic impairment, and the efficacy and safety of this medicine have not been studied in patients with severe hepatic impairment (Child Pugh class C).

This medication may increase the risk of cardiovascular mortality in patients with cardiovascular diseases; therefore, careful evaluation is needed for those with cardiovascular issues. Patients with hypersensitivity to this medication or those taking certain drugs (mercaptopurine, azathioprine) and individuals with genetically inherited lactose intolerance should not use this medication. Patients with a history of liver disease or thyroid dysfunction should undergo regular checks of liver function and thyroid function while using this medication, and those with ischemic heart disease or heart failure should use it cautiously. Concurrent use of this medication with theophylline may significantly increase renal excretory metabolites, necessitating caution during long-term use. This medication may temporarily worsen gout attacks at the start of administration; therefore, it should not be initiated until gout symptoms stabilize and gout attacks must be managed appropriately during treatment. As hepatic dysfunction may occur, liver function tests are recommended before and during administration, and use should be immediately discontinued if symptoms of liver function deterioration arise. This medication may cause drowsiness and dizziness; caution is required when driving or operating hazardous machinery. Severe allergic reactions or hypersensitivity reactions may occur rarely; if symptoms like rash or difficulty breathing arise, the administration should be stopped immediately, and healthcare providers should be consulted. This medication is not recommended for use during pregnancy, and it is advisable not to use while breastfeeding. There is no experience using this medication in children under 18, so it should not be administered, while it can be used in the elderly without special dosage adjustments, but with caution. In cases of overdose, there are no specific antidotes, and treatment should be symptomatic. This medication should be stored out of the reach of children and does not require special storage conditions. This medication may interact with other drugs, particularly it should not be used in conjunction with mercaptopurine, azathioprine, and caution is necessary with concomitant use of theophylline. There are no major issues when taken together with nonsteroidal anti-inflammatory drugs or antacids, but consultation with healthcare providers is necessary when taking.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, dyspnea, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movement frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, blood in stools, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbance, gait disturbance, flu-like symptoms, mass, pain, thirst, cholelithiasis, hyperglycemia, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramping, muscle single contractions, muscle tenacity, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, incomplete paralysis, sensory loss, olfactory loss, thermal infarction, somnolence, mental disorders, migraine, sensory abnormalities, drowsiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, nervous hyperreactivity, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive secretion from the sinuses, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin eruptions, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechial hemorrhages, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, extended activated partial thromboplastin time, increased creatinine, decreased bicarbonate, increased sodium, EEG abnormalities, increased glucose, increased cholesterol, increased triglycerides, increased amylase, increased potassium, increased thyroid-stimulating hormone, decreased platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea nitrogen ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urine output, decreased urine output, decreased lymphocyte count, decreased neutrophil count, increased leukocyte count, decreased leukocyte count, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reactions with systemic symptoms, liver failure, jaundice, liver impairment, agranulocytosis, rhabdomyolysis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best kept at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness of the medication for safe use.

Appearance

White to pale yellow round film-coated tablets

Package unit

30 tablets/bottle